FDA Approves Lucentis for Diabetic Macular Edema

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug 10, 2012 -
Genentech, a member of the Roche Group, today announced that Lucentis (ranibizumab
injection) was approved by the U.S. Food & Drug Administration
(FDA) for treatment of diabetic macular edema (DME), an eye
condition in people with diabetes that causes blurred vision,
severe vision loss and sometimes blindness. Diabetes is now the
leading cause of new cases of blindness in American
adults1 and DME is estimated to affect more than 560,000
Americans with the disease.2

Lucentis is the first and only FDA-approved medicine for DME, a
condition for which the standard of care has not changed
significantly in more than 25 years. To date, the standard of care
in the U.S. for DME has been laser surgery, which slows the rate of
vision loss and helps stabilize vision, but has demonstrated only
limited ability to restore lost vision.3

“For the first time, Americans with diabetic macular edema
will have access to an FDA-approved medicine shown to help many
patients rapidly regain substantial amounts of lost vision,”
said Hal Barron, M.D., chief medical officer and head, Global
Product Development. “We developed Lucentis to treat diseases
of the eye and are pleased to have received this third U.S.
indication to help a new population of people whose eyesight may be
affected by diabetes.”

“This approval is an important advancement in the
fight against blindness for people with diabetes,” said David
M. Brown M.D., Retinal Specialist at The Methodist Hospital,
Houston Texas, and clinical trial investigator. “Now that it
will be available, Lucentis therapy can begin to make a difference
in the lives of our patients with DME.”

Lucentis 0.5 mg once monthly was first approved by the FDA for
treatment of wet age-related macular degeneration (AMD) in 2006 and
for macular edema following retinal vein occlusion (RVO) in 2010.
Lucentis 0.3 mg once monthly was approved for DME, and physicians
can order immediately with shipments expected to begin August
15.

Lucentis Efficacy in DME

The approval of Lucentis in DME was based on Genentech's Phase
III trials, RIDE and RISE, two identically-designed, parallel,
double-masked, three-year clinical trials, which were
sham-treatment controlled for 24 months. A total of 759 patients
were randomized into three groups to receive monthly treatment with
0.3 mg Lucentis (n=250), 0.5 mg Lucentis (n=252) or sham injection
(control group, n=257). Primary outcomes were evaluated at 24
months and have been published in
Ophthalmology.4

More patients who received Lucentis
were able to read at least three additional lines (15 letters) on
the eye chart at 24 months: RIDE: 34 percent in the 0.3 mg group
versus 12 percent in the control group; RISE: 45 percent, 0.3 mg
versus 18 percent, control (primary endpoint)

Although uncommon, trends toward increased rates of
arteriothromboembolic events (ATEs) such as vascular death, deaths
of unknown cause, nonfatal heart attacks and nonfatal strokes, have
been observed in prior studies of Lucentis in other diseases.

Rates of these events were similar
among DME patients receiving 0.3 mg Lucentis and the control groups
at 24 months at 5.6 percent, 0.3 mg versus 5.2 percent, control.
The rate of ATE events at 36 months was 10.8 percent for patients
in the 0.3 mg treatment group (control period ended at 24
months).

The rate of stroke in DME patients at
24 months was 1.2 percent, 0.3 mg versus 1.6 percent, control. The
rate of stroke at 36 months was 2.0 percent for patients in the
0.3 mg treatment group.

Pooled analyses also showed the rate of fatal events (death from
any cause) in patients treated in the DME trials was low, and many
causes of death were not unusual for patients with advanced
diabetes complications. However, a potential relationship between
the events and intravitreal use of VEGF inhibitors cannot be
excluded. The rate of fatalities at 24 months was 2.8 percent, 0.3
mg versus 1.2 percent, control. The rate of fatalities at 36 months
was 4.4 percent for patients in the 0.3 mg treatment group.

About DME

DME is swelling of the macula, the central part of the retina
responsible for sharp, central vision.5 DME begins with
diabetes, which can cause damage to blood vessels in the eye over
time. When this happens, a patient is said to have diabetic
retinopathy, the most common diabetic eye disease. The damaged
blood vessels can leak blood and fluid, causing swelling and
blurred vision, severe vision loss and sometimes
blindness.5

Nearly 26 million Americans have diabetes, which has become the
leading cause of new cases of blindness in adults aged
20-74.1 Among Americans aged 40 years and older, more
than 4.2 million have diabetic retinopathy, according to the
2005-2008 National Health and Nutrition Examination Survey
(NHANES).6 A subsequent analysis estimates that 560,500
have DME.2 It has also been estimated that up to 10
percent of people with diabetes will get DME during their
lifetime.7

About Lucentis

Lucentis is a prescription medicine for the treatment of
patients with wet AMD, macular edema following RVO and DME.

Lucentis is a recombinant humanized monoclonal antibody fragment
(lacking an Fc region). Lucentis is the first VEGF inhibitor
specifically designed for use in the eye to bind to and inhibit
VEGF-A, a protein that is believed to play a critical role in the
formation of new blood vessels (angiogenesis) and the
hyperpermeability (leakiness) of the vessels.

In wet AMD, these new blood vessels grow under the retina and
leak blood and fluid, causing rapid damage to the macula. Lucentis
administered monthly in wet AMD clinical trials demonstrated an
improvement in vision of three lines or more on the study eye chart
in up to 41 percent of patients at two years. Nearly all patients
(90 percent) treated monthly with Lucentis in those trials
maintained (defined as losing < 15 letters) vision.

In RVO, angiogenesis and hyperpermeability can lead to macular
edema, the swelling and thickening of the macula. Lucentis
administered at 0.5 mg monthly in RVO clinical trials demonstrated
the following average vision gains for patients at six months:
patients with branch-RVO experienced an average gain of 18.3
letters on the study eye chart (compared to 7.3 letters for the
control group) and patients with central-RVO experienced an average
gain of 14.9 letters on the study eye chart (compared to 0.8
letters for the control group).

Lucentis has been rigorously studied in multiple retinal
diseases in 27 clinical trials involving more than 10,500 patients
worldwide.

Outside the U.S., Lucentis has received regulatory approval for
treatment of visual impairment due to DME in more than 75
countries, for treatment of wet AMD in more than 100 countries and
for treatment of RVO in more than 70 countries.

Lucentis was discovered by Genentech and is being developed by
Genentech and Novartis for diseases or disorders of the eye.
Genentech retains commercial rights in the U.S. and Novartis has
exclusive commercial rights for the rest of the world.

Lucentis Safety

Lucentis is a prescription medicine given by injection into the
eye, and it has side effects. Lucentis is not for everyone. You
should not use Lucentis if you have an infection in or around the
eye or are allergic to Lucentis or any of its ingredients.

Some Lucentis patients have serious side effects related to the
injection. These include serious infections inside the eye,
detached retinas, and cataracts. Other uncommon serious side
effects include inflammation inside the eye and increased eye
pressure. These side effects can make your vision worse. Some
patients have had increased eye pressure within one hour of an
injection. Your eye doctor should check your eye pressure and eye
health during the week after your Lucentis injection.

Uncommonly, Lucentis patients have had serious, sometimes fatal,
problems related to blood clots, such as heart attacks or
strokes.

If your eye becomes red, sensitive to light, or painful, or if
you have a change in vision, call or visit your eye doctor right
away.

The most common eye-related side effects are increased redness
in the white of the eye, eye pain, small specks in vision, and
increased eye pressure. The most common non-eye-related side
effects are nose and throat infections, headache, lung/airway
infections, and nausea.

Lucentis is for prescription use only.

For additional safety information, please talk to your doctor
and visit
http://www.lucentis.com for the Lucentis full prescribing
information.

Genentech's Commitment to Patient Access

At Genentech, we develop medicines for serious or
life-threatening medical conditions and we believe they should be
accessible for the patients who need them. Genentech Access
Solutions is here to help when a Genentech medicine is
prescribed. We offer a full range of programs and services to
meet the needs of patients and health care professionals. What
patients need for access—from benefits investigations through
patient assistance options—is available through Genentech
Access Solutions. For more information, please
visit Genentech-Access.com.

About Genentech

Founded more than 30 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious or
life-threatening medical conditions. The company, a member of the
Roche Group, has headquarters in South San Francisco, California.
For additional information about the company, please visit
http://www.gene.com.

References:

1[CDC] Centers for Disease Control and Prevention.
National diabetes fact sheet: national estimates and general
information on diabetes and prediabetes in the United States, 2011.
Atlanta, GA: U.S. Department of Health and Human Services, Centers
for Disease Sham and Prevention [resource on the internet; updated
2011; cited 2012 May 25]. Available at:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.

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